Anterior Chamber Angle Congestion, Choroid Disease, Macula Edema, Macular Pigmentation, Posterior Capsule Opacification, Retinal Degeneration, Retinal Detachment
Conditions
Keywords
Posterior Capsule Opacification, Macular Pigment Optical Density, Anterior Chamber Parameters, Nd: YAG Laser Posterior Capsulotomy, Posterior Capsulotomy, Cystoid Macular Edema, Choroidal Thickness
Brief summary
It has been hypothesized that potential effects of laser Nd: YAG laser posterior capsulotomy may affect macular pigment as well as choroidal thickness, macular thickness and anterior chamber parameters, so it was aimed to investigate possible effects of Nd: YAG laser posterior capsulotomy on macular pigment optical density, choroidal thickness, macular thickness and anterior chamber parameters in cases with posterior capsule opacification in this study.
Detailed description
This clinical trial was conducted following the principles of the Declaration of Helsinki. The local authorized clinical trials ethics committee approved the protocol and consent forms (Afyon Kocatepe University Clinical Trials Ethics Committee, 2011-KAEK-2 2017/172). Between 2015 and 2016, 38 pseudophakic participants were enrolled in this study. After providing information to patients about the disease and treatment, patients predicted to show adherence to treatment, were enrolled in the study. Detailed ophthalmological examinations of all subjects were performed prior to Nd: YAG laser posterior capsulotomy intervention. Anterior chamber parameters of cases with PCO were measured Measurements of IOP, anterior chamber parameters, visual acuity, Slit-lamp, gonioscopy and fundus examinations, and measurements of central macular thickness (CMT), choroidal thicknesses (CTs), and MPOD were performed after maximal pupil dilatation. Proposed procedure, including risks, benefits, and alternatives were discussed with all subjects, and all participants signed of informed consent form. Choroidal thicknesses were recorded as subfoveal CT (SCT), nasal CT (NCT) and temporal CT (TCT). MPOD measurements were subsequently made by using luminance differential thresholds test. After measurements a refractive surgery specialist carried out Nd: YAG laser posterior capsulotomy interventions to patients who were decided to applying Nd:YAG laser capsulotomy. All examinations and measurements were repeated and recorded at 1st week, 1st and 2nd month.
Interventions
DEVICENd: YAG laser posterior capsulotomy
Nd: YAG laser posterior capsulotomy
Sponsors
Afyon Kocatepe University Hospital
Study design
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
sequential self-controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Best-corrected visual acuity (BCVA) logMAR \<0.3 * Duration at least 2 years after cataract surgery * Between the ages of 45 and 65 years (45≤age≤65)
Exclusion criteria
* Corneal scarring, diffuse posterior PCO or intravitreal hemorrhage that prevents appearance of the fundus * Occluded angle by gonioscopy (grade 0, narrow angle, grade I, grade II) * Presence of macular or peripheral retinal pathologies or choroidopathy * High risk for RD * Presence of macular edema in the macular area * Detection of macular fluid or edema in OCT * Active intraocular inflammation * Previous laser PRP, Nd: YAG laser posterior capsulotomy, laser iridotomy or selective laser trabeculoplasty interventions * Previous iridectomy, glaucoma or vitreoretinal surgery * Glass intraocular lens * Spherical refractive error ≥ ±6.00 D or cylinder refractive error ≥ ±3.00 D * Inadequate stability of the eye * Systemic diseases that may affect the choroidal blood flow such as cardiological diseases * Current use of carotenoid supplementation * Changing eating habits * Gastrointestinal diseases that could cause disturbance of dietary absorption
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months | 2 months | Foveal and pericentral pigment optical density was measured by using color perimetry technique and recorded as log unit before Nd: YAG laser posterior capsulotomy, at 1 week, 1 month and 2 months |
| Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months | 2 months | Subfoveal, temporal and nasal choroidal thicknesses were measured by using enhanced-deep imaging optical coherence tomography and recorded as micrometer before Nd: YAG laser posterior capsulotomy, at 1 week, at 1-month and at 2-month |
| Changes of Anterior Chamber Depth (Millimeter) From Baseline at 2 Months | 2 months | Anterior chamber depth was measured by using anterior segment module optical coherence tomography and recorded as millimeter before Nd: YAG laser posterior capsulotomy, at 1 week, at 1-month and at 2-month |
| Changes of Iridocorneal Angle From Baseline at 2 Months | 2 months | Iridocorneal angle was measured by using anterior segment module optical coherence tomography and recorded as millimeter before Nd: YAG laser posterior capsulotomy, at 1 week, at 1-month and 2-month |
Secondary
| Measure | Time frame |
|---|---|
| Changes of Central Macular Thicknesses (Micrometer) From Baseline at 2 Months | 2 Months |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nd: YAG Laser Posterior Capsulotomy Posterior capsulotomy was performed by using Nd: YAG laser and macular pigment optical density, intra ocular pressure, choroidal thickness, macular thickness and anterior chamber parameters were measured before Nd: YAG laser, at 1 week, 1 month and 2 months
Nd: YAG laser posterior capsulotomy: Nd: YAG laser posterior capsulotomy | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | Nd: YAG Laser Posterior Capsulotomy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants |
| Age, Continuous | 55.37 years STANDARD_DEVIATION 4.45 |
| Region of Enrollment Turkey | 38 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 38 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Changes of Anterior Chamber Depth (Millimeter) From Baseline at 2 Months
Anterior chamber depth was measured by using anterior segment module optical coherence tomography and recorded as millimeter before Nd: YAG laser posterior capsulotomy, at 1 week, at 1-month and at 2-month
Time frame: 2 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nd: YAG Laser Posterior Capsulotomy | Changes of Anterior Chamber Depth (Millimeter) From Baseline at 2 Months | ACD at baseline | 3.7 millimeter | Standard Deviation 0.06 |
| Nd: YAG Laser Posterior Capsulotomy | Changes of Anterior Chamber Depth (Millimeter) From Baseline at 2 Months | ACD at 1-week | 3.73 millimeter | Standard Deviation 0.06 |
| Nd: YAG Laser Posterior Capsulotomy | Changes of Anterior Chamber Depth (Millimeter) From Baseline at 2 Months | ACD at 1-month | 3.74 millimeter | Standard Deviation 0.06 |
| Nd: YAG Laser Posterior Capsulotomy | Changes of Anterior Chamber Depth (Millimeter) From Baseline at 2 Months | ACD at 2-month | 3.75 millimeter | Standard Deviation 0.07 |
Primary
Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months
Foveal and pericentral pigment optical density was measured by using color perimetry technique and recorded as log unit before Nd: YAG laser posterior capsulotomy, at 1 week, 1 month and 2 months
Time frame: 2 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nd: YAG Laser Posterior Capsulotomy | Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months | MPOD fovea at baseline | 0.55 log unit | Standard Deviation 0.07 |
| Nd: YAG Laser Posterior Capsulotomy | Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months | MPOD fovea at 1-week | 0.52 log unit | Standard Deviation 0.08 |
| Nd: YAG Laser Posterior Capsulotomy | Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months | MPOD fovea at 1-month | 0.51 log unit | Standard Deviation 0.09 |
| Nd: YAG Laser Posterior Capsulotomy | Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months | MPOD fovea at 2-month | 0.5 log unit | Standard Deviation 0.09 |
| Nd: YAG Laser Posterior Capsulotomy | Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months | MPOD pericentral at baseline | 0.33 log unit | Standard Deviation 0.05 |
| Nd: YAG Laser Posterior Capsulotomy | Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months | MPOD pericentral at 1-week | 0.31 log unit | Standard Deviation 0.05 |
| Nd: YAG Laser Posterior Capsulotomy | Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months | MPOD pericentral at 1-month | 0.3 log unit | Standard Deviation 0.06 |
| Nd: YAG Laser Posterior Capsulotomy | Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months | MPOD pericentral at 2-month | 0.29 log unit | Standard Deviation 0.06 |
p-value: <0.01ANOVA
Primary
Changes of Iridocorneal Angle From Baseline at 2 Months
Iridocorneal angle was measured by using anterior segment module optical coherence tomography and recorded as millimeter before Nd: YAG laser posterior capsulotomy, at 1 week, at 1-month and 2-month
Time frame: 2 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nd: YAG Laser Posterior Capsulotomy | Changes of Iridocorneal Angle From Baseline at 2 Months | ICA at baseline | 36.59 degree | Standard Deviation 1.22 |
| Nd: YAG Laser Posterior Capsulotomy | Changes of Iridocorneal Angle From Baseline at 2 Months | ICA at 1-week | 39.92 degree | Standard Deviation 2.1 |
| Nd: YAG Laser Posterior Capsulotomy | Changes of Iridocorneal Angle From Baseline at 2 Months | ICA at 1-month | 41.62 degree | Standard Deviation 3.39 |
| Nd: YAG Laser Posterior Capsulotomy | Changes of Iridocorneal Angle From Baseline at 2 Months | ICA at 2-month | 42.04 degree | Standard Deviation 4.18 |
Primary
Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months
Subfoveal, temporal and nasal choroidal thicknesses were measured by using enhanced-deep imaging optical coherence tomography and recorded as micrometer before Nd: YAG laser posterior capsulotomy, at 1 week, at 1-month and at 2-month
Time frame: 2 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nd: YAG Laser Posterior Capsulotomy | Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months | Subfoveal choroidal thickness baseline | 276.46 micrometer | Standard Deviation 19.36 |
| Nd: YAG Laser Posterior Capsulotomy | Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months | Subfoveal choroidal thickness at 1-week | 276.54 micrometer | Standard Deviation 19.45 |
| Nd: YAG Laser Posterior Capsulotomy | Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months | Subfoveal choroidal thickness at 1-month | 276.86 micrometer | Standard Deviation 19.42 |
| Nd: YAG Laser Posterior Capsulotomy | Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months | Subfoveal choroidal thickness at 2-month | 276.76 micrometer | Standard Deviation 19.36 |
| Nd: YAG Laser Posterior Capsulotomy | Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months | Temporal choroidal thickness at baseline | 275.04 micrometer | Standard Deviation 20.59 |
| Nd: YAG Laser Posterior Capsulotomy | Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months | Temporal choroidal thickness at 1-week | 275.02 micrometer | Standard Deviation 20.67 |
| Nd: YAG Laser Posterior Capsulotomy | Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months | Temporal choroidal thickness at 1-month | 275.23 micrometer | Standard Deviation 20.64 |
| Nd: YAG Laser Posterior Capsulotomy | Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months | Temporal choroidal thickness at 2-month | 275.03 micrometer | Standard Deviation 20.56 |
| Nd: YAG Laser Posterior Capsulotomy | Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months | Nasal choroidal thickness at baseline | 271.16 micrometer | Standard Deviation 19.64 |
| Nd: YAG Laser Posterior Capsulotomy | Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months | Nasal choroidal thickness at 1-week | 271.33 micrometer | Standard Deviation 19.74 |
| Nd: YAG Laser Posterior Capsulotomy | Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months | Nasal choroidal thickness at 1-month | 271.75 micrometer | Standard Deviation 19.71 |
| Nd: YAG Laser Posterior Capsulotomy | Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months | Nasal choroidal thickness at 2-month | 271.74 micrometer | Standard Deviation 19.62 |
Secondary
Changes of Central Macular Thicknesses (Micrometer) From Baseline at 2 Months
Time frame: 2 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nd: YAG Laser Posterior Capsulotomy | Changes of Central Macular Thicknesses (Micrometer) From Baseline at 2 Months | Central Macular Thickness Baseline | 235.79 micrometer | Standard Deviation 13.48 |
| Nd: YAG Laser Posterior Capsulotomy | Changes of Central Macular Thicknesses (Micrometer) From Baseline at 2 Months | Central Macular Thickness 1-week | 243.08 micrometer | Standard Deviation 14.32 |
| Nd: YAG Laser Posterior Capsulotomy | Changes of Central Macular Thicknesses (Micrometer) From Baseline at 2 Months | Central Macular Thickness 1-month | 244.76 micrometer | Standard Deviation 14.82 |
| Nd: YAG Laser Posterior Capsulotomy | Changes of Central Macular Thicknesses (Micrometer) From Baseline at 2 Months | Central Macular Thickness 2-month | 245.5 micrometer | Standard Deviation 15.24 |